Featured Articles

  1. Oral Solutions & Suspensions: The Art Of Pharmacy 5/12/2022

    Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.

  2. Demystifying Highly Potent API And Cytotoxic Drug Products

    The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing.

  3. Supply Chain Transformation, 503B And Reducing Drug Shortages 9/11/2020

    Currently there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.

  4. Applying Quality By Design To Pharmaceutical Research And Development 12/1/2020

    QbD is often discussed in the context of process development and manufacturing. We focus on QbD applied to R&D to drive better results throughout the drug development process.

  5. The Art And Science Of Tech Transfer – Transferring Vaccine Production

    Facilities committed to prioritizing COVID-19 production are forcing non-COVID-19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case. 

  6. Accelerating The Start Of Your Outsourced Pharmaceutical Project: Role Of The Project Technical Review -- Part 2

    Part 2 in this series focuses on the gap between project tech review and the assessing a potential CDMO's capabilities and anticipated project timing to determine necessary resources and outline deliverables.

  7. Oxygen Sensitive Drug Products

    Primary packaging is thought of as the first line of defense against the negative effects of oxygen. This article highlights other areas to consider that can help avoid drug quality degradation.

  8. 5 Key Factors For A Successful Tech Transfer

    Each tech transfer comes with a unique set of complex processes that need to be understood. While it includes the transfer of analytical methods and manufacturing processes, there is also a human dimension to consider.

  9. The Value Of Orphan Drug Designation

    More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.

  10. Navigating An Ever-Changing Landscape: The Role Of A CFO In A Private Equity Controlled Pharma Company

    The role of Chief Financial Officer for a small-to-mid size pharma company controlled by private equity is a challenging one, especially since pharma companies with limited internal resources often rely on CDMOs for support. Learn how these CFOs can use their CDMOs to be more successful.